FDA Adverse Event
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2802210
·
Received October 23, 2012
Report
- Report Number
- 1531186-2012-01231
- Date Received
- October 23, 2012
- Report Date
- October 19, 2012
- Manufacturer
- JUMAO MEDICAL EQUIPMENT
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE UPHOLSTERY FOR THIS CHAIR IS COMPLETELY TORN APART AT THE SEAM. THE REPORTER OF THIS EVENT WAS CONTACTED FOR ADDITIONAL ON THIS INCIDENT. IT WAS LEARNED THE WHEELCHAIR WAS ISSUED TO AN END USER WHO RESIDES IN AN ASSISTED LIVING FACILITY. HE REPORTEDLY USES THIS CHAIR FULL TIME. ALSO NOTED WAS THE BAR UNDER THE SEAT IS COMING THROUGH THE SEAT. NO REPORTED INJURY HAS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | JUMAO MEDICAL EQUIPMENT | V20RFR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 MO | Other |